Recommendations for the validation of flow cytometric testing during drug development: II assays

Journal of Immunological Methods

Volumn 363, Issue 2, 2011, Pages 120-134

  O'Hara, Denise M ^a   Xu, Yuanxin ^b   Liang, Zhiyan ^c   Reddy, Manjula P ^d   Wu, Dianna Y ^e   Litwin, Virginia ^f  

^a PFIZER INC   (United States)

^b GENZYME CORPORATION   (United States)

^c MEDIMMUNE   (United States)

^d CENTOCOR INC   (United States)

^e BRISTOL MYERS SQUIBB   (United States)

^f Labcorp Drug Development   (United States)

Author keywords

Biomarker assays; Flow cytometry; Immunogenicity assays; Pharmacodynamic assays; Pharmacokinetics assays; Validation

Indexed keywords

BIOLOGICAL MARKER;

ANTIGEN EXPRESSION; ARTICLE; B LYMPHOCYTE; CELL COUNT; FLOW CYTOMETRY; HUMAN; IMMUNOGENICITY; LIGAND BINDING; PRIORITY JOURNAL; T LYMPHOCYTE; VALIDATION STUDY;

DRUG DISCOVERY; FLOW CYTOMETRY; FLUORESCENT ANTIBODY TECHNIQUE; PHARMACEUTICAL PREPARATIONS; REPRODUCIBILITY OF RESULTS; VALIDATION STUDIES AS TOPIC;

EID: 78650047219     PISSN: 00221759     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jim.2010.09.036     Document Type: Article

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